Cleared Abbreviated

K080598 - MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS

K080598 is an FDA 510(k) clearance for MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM P..., manufactured by Intra-Lock International. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K080598 · Intra-Lock International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
79d
Days
Class 2
Risk

K080598 is an FDA 510(k) clearance for the MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Intra-Lock International (Boca Raton, US). The FDA issued a Cleared decision on May 21, 2008 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Intra-Lock International devices

FDA 510(k) Submission Details - K080598

510(k) Number K080598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date May 21, 2008
Days to Decision 79 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 561
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